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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-I; VENTILATOR, CONTINUOUS, FACILITY USE
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MAQUET CRITICAL CARE AB SERVO-I; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Catalog Number UNKNOWN
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 05/28/2019
Event Type  malfunction  
Event Description
It was reported that the ng tube for nava (neurally adjusted ventilatory assist) was found broken a few hours after its placement into the patient.The final patient outcome is unknown.Manufacturer reference #: (b)(4).
 
Manufacturer Narrative
The only information that was received stated that there was no patient harm and the measures that were taken was to remove the edi-catheter from the patient.The batch number was also provided.No further information has been received despite attempt to obtain it.The problem description information was inadequate to determine the fault that was experienced.No parts or pictures were provided therefore the investigation consist of only checking whether there have been any issues with the batch number and no other issues have been found.The reported event cannot be confirmed and the true cause has not been determined.H3 other text : not returned and no further information.
 
Event Description
Manufacturer's ref.#: (b)(4).
 
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Brand Name
SERVO-I
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
MDR Report Key8821219
MDR Text Key152025253
Report Number8010042-2019-00534
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K123149
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received10/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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